Our offer
In response to the interests of our clients we constantly modernise our services. We offer you a wide range of services, among others:
REGISTRATION DOSSIER
- Non-clinical and clinical expert report in CTD format
- Overall quality summary and module 3 CTD
- Elaboration of qualitative and quantitative recipes
- Elaboration of analytical methods with validation
- Management of registration procedures on behalf of Marketing Authorisation Holder
- Local Marketing Authorisation Holder representation in the scope of medicinal products registration procedures
INFORMATION LEAFLET
- Preparation of information leaflet set (Summary of Product Characteristic, Patient information leaflet, package labelling) based on current law and QRD requirements
- Periodical updates of information leaflet text.
We have elaborated over 100 information leaflet sets, mainly in accordance with European procedures.
PROFESSIONAL TRANSLATION SERVICES
- We prepare professional translation of registration dossier (quality documentation, non-clinical and clinical reports), articles and scientific reports.
